Kornimate/medical-research-clean huggingface dataset:
comparative pharmacokinetics of a compounded 6-mercaptopurine liquid formulation preparation and tablets

Conditions: Acute Lymphoblastic Leukemia

Summary: the purpose of this study is to compare the pharmacokinetics of a routinely used compounded liquid formulation of 6-mercaptopurine (6-mp) with commercially available tablets in patients who are receiving treatment with 6-mp as part of their clinical treatment for acute lymphoblastic leukemia (all).


Eligibility criteria:
inclusion criteria: * patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for all with 6-mp will be included. exclusion criteria: * inability to have blood drawn for the screening lab tests * received methotrexate or folate supplement within the last 24 hours * pregnant or lactating females * inability to swallow a pill * hemoglobin less or equal to 8 gm/dl * presence of significant co-morbid illness that makes child ineligible as deemed by the investigator * weight \< or = 16 kg

Keywords: all acute lymphoblastic leukemia 6-mercaptopurine pediatric
a study to assess pregnancy outcomes in women exposed to diroximel fumarate

Conditions: Multiple Sclerosis

Summary: the primary objective of the study is to estimate the prevalence of major congenital malformations (mcms) and compare the prevalence between the diroximel fumarate (drf) and comparator groups. the secondary objectives of the study are to estimate the incidence of spontaneous abortion (sa) and compare the incidence between the drf and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the drf and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the drf and comparator groups and to estimate the prevalence of small for gestational age (sga) and compare the prevalence between the drf and comparator groups.


Eligibility criteria:
key inclusion criteria: * last menstrual period (lmp) between 29 october 2019 and 31 july 2030. * continuous medical and pharmacy coverage for a minimum of 6 months prior to and including the estimated lmp. * presence of ms. key exclusion criteria: - pregnancies will be excluded from this study if they are exposed to any known teratogens from the beginning of baseline through the end of the relevant exposure window. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: pregnancy relapsing forms of multiple sclerosis (ms)
evaluate heart failure patients with specially designed patient adherence and monitoring software on standard mobile devices

Conditions: Cardiac Decompensation

Summary: this is planned as a feasibility study. the objective is to evaluate a specially designed patient adherence and monitoring software on standard mobile devices in remote monitoring of heart failure patients.

heart failure is a common cardiovascular problem which is increasing in both prevalence and incidence and associated with substantial morbidity and mortality. the management of heart failure patients is complex and has become a priority world over. effective methods to keep heart failure patients out of the hospital are essential, both in the interests of the patient's health, as well as to reduce the burden on the health care system. heart failure patients should be in a position to provide readings of their weight, blood pressure, fluid intake, medications and other important parameters and communicate this data to care providers using wireless technology. this data should be made available to medical personnel regularly and on a periodic basis. in this manner the health care providers can detect and respond to warning signs or alerts before the patient's condition worsens to warrant a visit to the doctor or a hospital admission with features of heart failure decompensation.

Eligibility criteria:
inclusion criteria: * subjects of either gender above the age of 18 years * the subject is able and willing to provide written informed consent prior to enrollment in the study * new york heart association (nyha) classification class of ii-iv * left ventricular ejection fraction (lvef) less than 40% * one or more prior hospitalization within the last six months for symptoms, management of heart failure. exclusion criteria: * disability of fingers or upper limbs (unable to use devices) * visually impaired * those unable to read and write * hearing dysfunction * significant cognitive disabilities, mental illness * those who are unable to handle electronic devices * those residing in places outside the local mobile phone coverage * chronic renal failure on renal replacement therapy * patients who may not come for follow up or likely to drop out of the study * those awaiting cardiac transplantation * any illness which may preclude regular follow up

Keywords: vascular diseases hypertension chronic kidney disease copd
comparison of the hemodynamic safety of two common alveolar recruitment manoeuvres with regard to cardiac output in a surgical intensive care unit

Conditions: Positive-Pressure Respiration

Summary: protective ventilation - combining a low tidal volume (between 6 and 8 ml/kg) and alveolar recruitment (ar) manoeuvres repeated every 30 minutes - is currently the standard of care for decreasing morbidity associated with mechanical ventilation. in contrast, there is no consensus on the type of recruitment manoeuvre, which varies from one centre to another and from one study to another. the investigators intend to compare two currently used ar techniques with regard to their ventilatory efficacy and hemodynamic safety: * an end-tidal plateau at 30 cmh20 for 30 seconds. * an end-tidal plateau at 10 cmh20 above the patient's plateau pressure for 30 seconds, without exceeding 30 cmh20.


Eligibility criteria:
inclusion criteria: * all sedated, intubated, mechanically ventilated adult patients (over-18) admitted to the surgical intensive care unit and equipped with a central venous catheter and an arterial catheter. * good echogenicity * social security coverage exclusion criteria: * pregnancy * cardiac arrhythmia * poor echogenicity * legal guardianship or incarceration * systolic blood pressure ≤90 mmhg * respiratory distress * patients admitted on an emergency basis (first 24 hours), i.e. not for elective surgery

Keywords: alveolar recruitment stroke volume/physiology cardiac output/physiology
open-label study of pocenbrodib alone and in combination with abiraterone acetate, olaparib, or 177lu-psma-617

Conditions: mCRPC (Metastatic Castration-resistant Prostate Cancer); Genital Neoplasms, Male; Urogenital Neoplasms; Urogenital Cancers; Prostatic Diseases; Prostatic Neoplasms; Male Urogenital Diseases; Neoplasms; Neoplasms by Site; Prostate Cancer

Summary: this is a dose-finding study to assess the safety and preliminary antitumor activity of pocenbrodib alone or with abiraterone acetate, olaparib or 177lu-psma-617 in patients with metastatic castration-resistant prostrate cancer (mcrpc).

this is a phase 1b/2a multicenter, open-label study to confirm the safety, pharmacokinetics (pk), preliminary antitumor activity, and pharmacodynamics (pd) of pocenbrodib for the treatment of participants with mcrpc who have progressed despite prior therapy and have been treated with at least 1 potent anti-androgen therapy (enzalutamide, apalutamide, abiraterone acetate, or darolutamide). the phase 1b portion of the study involves pocenbrodib monotherapy at multiple, sequential five rising doses (50, 100, 150, 200, and 250mg) initially using a qd dosing schedule of 5 days on/2 days off. the first dose level (50 mg) will enroll at least 3 participants (with 3 more added if the first 3 participants yield 1 dose-limiting toxicity). once safety is confirmed through data review committee (drc), the next higher pocenbrodib dose level cohort can begin enrollment. if both acceptable safety and minimal threshold of efficacy (predefined as 30% psa50 are achieved, the sponsor will proceed to phase 2a. phase 2a will enroll participants in each of 4 cohorts: pocenbrodib monotherapy (2a), and 3 combination therapy cohorts: pocenbrodib + abiraterone acetate (2b), pocenbrodib + olaparib (2c), and pocenbrodib + 177lu-psma-617 (2d). all cohorts may enroll in parallel, but each cohort will be evaluated independently for safety and efficacy.

Eligibility criteria:
key inclusion criteria: 1. ≥18 years of age 2. histologic documentation of prostate adenocarcinoma 3. metastatic disease, documented by imaging. imaging performed within 56 days prior to screening is acceptable key exclusion criteria: 1. current or prior evidence of any small cell or neuroendocrine histology on the most recent prostate biopsy 2. any liver metastases confirmed by biopsy or evidence of lesions \>1 cm consistent with liver metastases on imaging 3. intervention with any chemotherapy, investigational agent, or other anticancer drug, including enzalutamide, apalutamide, or darolutamide, 14 days prior to screening or 5 half-live20. 4. any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which in the judgment of the investigator may interfere with study participation and compliance or place the participant at high risk from treatment-related complicationss from the last dose (whichever is shorter)

Keywords: mcrpc, metastatic castrate resistant prostate cancer, prostate cancer, procenbrodib castration resistant
how altered gut-brain-axis influences food choices: part 2 (brainfood)

Conditions: Food Preferences; Obesity

Summary: obesity is currently one of the most substantial health burdens. due to the production of marked and sustained weight loss, bariatric surgery is an increasingly used therapeutic modality to combat obesity and its comorbidities. surgical rearrangement of the gastrointestinal tract remarkably alters metabolism and hormones acting on neurological and hypothalamic signalling, involved in food decision-making and eating behaviour. in this context, many patients who underwent bariatric surgery self-report changes in appetite, satiety and food preferences. furthermore, new gut hormone-based (e.g. glp-1 receptor agonist or glp-1-ra) pharmacotherapies which mimic the effect of bariatric surgery show impressive efficacy on weight reduction by modulation of food behaviour. however, the mechanisms of such functional changes, and how they relate to food decision-making and food purchase behaviour remain unknown. in part 2 of the brainfood-project, the investigators propose a novel approach using digital receipts from loyalty card to unravel the effect of obesity treatments (surgical and non-surgical) on eating and food purchase behaviour in daily life.

the overall aim of this project is to elucidate the changes in food behaviour among obese adults undergoing obesity treatments. the main objective is to observe the effect of obesity treatments on food purchase behaviour using digital receipts from grocery shopping. the investigators hypothesize that bariatric surgery leads to changes in food purchase behaviour in obese adults. the further objective is to compare food purchase behaviour between obese adults against values of an existing reference population, and to assess whether these differences tend to be reduced after the start of the treatment among obese participants.

Eligibility criteria:
inclusion criteria: * female and male subjects aged 18 years or older * proficient in german (including written) * bmi≥30kg/m2 or bmi≥28kg/m2 with adiposity-related comorbidities (prediabetes, type 2 diabetes mellitus, hypertension, dyslipidemia) * referred for obesity treatment or who started obesity treatment within 6 months (surgical or non-surgical) * primary grocery shopping at the swiss biggest grocery retailers (coop, migros), and regularly using a loyalty card (cumulus and/or supercard) exclusion criteria: * incapacity to give informed consent * primary shopping in other food retailers (e.g. aldi, lidl, outside of switzerland, etc.)

Keywords: bariatric surgery food preferences food behaviour digital receipts grocery shopping obesity treatment glp-1 receptor agonist
covid-19 vaccine for indirect protection

Conditions: Vaccine Preventable Disease

Summary: the primary objective of this study is to test whether vaccinating adults ≥18 years in hutterite colonies with mrna-1273 (moderna covid-19) vaccine as compared to control (usual care) can prevent rt-pcr confirmed covid-19 in non-vaccinated hutterite members.

despite the efficacy that has been demonstrated in phase iii randomized controls trials of mrna covid-19 vaccines, a critical question that remains unanswered is whether mrna vaccines lead to herd immunity. the rationale for conducting this study is to learn whether vaccinating adults with a covid-19 vaccine will prevent covid-19 infections in non-vaccinated community members. hutterite communities are unique since they are isolated from towns and cities and also share a number of communal activities, such as eating meals and attending church. because of their location and practices, the hutterite colonies give an opportunity to see whether vaccinating some hutterite members with the covid vaccine provides protection to the whole group. if the study shows that immunizing some of the population reduces the level of covid-19 infection for other members of the population, this may be very important in stopping the covid-19 pandemic and future pandemics.

Eligibility criteria:
group a: anyone other than the adults aged ≥18 years who are vaccinated inclusion criteria: * individuals under the age of 18 * individuals with a contraindication to study vaccines * those not willing to be vaccinated but consent to follow up exclusion criteria: - there are no exclusion criteria for this category of participants: group b: adults aged 18 years or older, who will be vaccinated as part of the intervention. exclusion criteria: * anaphylactic reaction to any component of the study vaccine or to a previous dose of the study vaccines * pregnancy

Keywords: vaccination herd immunity covid-19
effect of cannabis (marijuana) on stomach emptying before surgery

Conditions: Gastric Emptying; Cannabis

Summary: the purpose of this research is to study the effect of cannabis (marijuana) on gastric (stomach) emptying before surgery. the study will include people who use cannabis (study group) and people who do not use cannabis (control group).

about 108 people will take part in this study (54 in the study group and 54 in the control group). subjects will have an ultrasound of the abdomen before their scheduled surgery. the ultrasound will determine how much fluid remains in the abdomen. researchers will also review subjects' medical records and will include: age, body mass index, history of cannabis use including how often and how consumed, reason for surgery, and length of time without eating before surgery.

Eligibility criteria:
inclusion criteria: * subjects 18 years and older * planned surgery at one of two hospitals within the healthcare system * willing to state if they use or do not use cannabis * able to read and consent on their own behalf exclusion criteria: * cognitively impaired * unable to read * children under the age of 18 * pregnant women - pregnancy status will be obtained from the routine pregnancy test performed prior to surgery * history of gastroparesis * gastric surgeries * advanced liver or renal dysfunction * critically ill * emergent/urgent cases
transplantation of autologous mesenchymal stem cell in decompensate cirrhotic patients with pioglitazone

Conditions: Liver Fibrosis

Summary: liver cirrhosis (lc) is the final destiny in chronic liver disease. liver transplantation is the only effective therapy available to these patients. however, limited number of donors, post surgical complications, immunological rejection, and financial considerations are it's essential problems. the immuomodulatory impact of mscs in fibrosis was confirmed, and several clinical studies have applied mscs to eliminate the progression of fibrosis. in this research the investigators will study the affect of mscs and pioglitazone in the process of fibrosis.

bm aspiration will be done twice (6 months interval) from the iliac crest according to standard procedures under general anesthesia and is collected (200ml) in plastic bags containing anti coagulant. after precipitation of red blood cells, mononuclear cells will be collected by centrifugation in ficoll-paque density gradient. mncs will be cultured in t150 flasks. cells will be expanded in several subcultures.mscs will be injected (6 months interval) via portal vein under sonography monitoring.each patient will receive 30mg pioglitazone daily for 24 months. after cell therapy, patients are followed up every week for 6 months, and laboratory data are analyzed for 6 months.

Eligibility criteria:
inclusion criteria: * 18-65 years cirrhotic patient * approved cirrhosis by elastografy ,biopsy, sonography exclusion criteria: 1 - portal vein thrombosis 2-hepatic encephalopathy, score 3\&4 3-alt \& ast 3times more than normal 4-serum cr more than 1/5mg/dl 5-(anti-hiv +) (anti-hcv+) (hbs-ag+) 6-hepatocel carcinoma 7- primary sclerosing cholangitis (psc) 8- esophageal varices grade 4 9-addiction 10-child score b,c

Keywords: mscs pioglitazon fibrosis liver
pro-adm vs pct in patients with complications post hematopoietic stem cell transplantation

Conditions: Stem Cell Transplant Complications

Summary: prospective, multicenter, spontaneous, non-interventional, non pharmacological. study aimed at evaluate kinetics, diagnostic and prognostic value of pro-adm (proadrenomedullin) as compared to pct (procalcitonin) in patients presenting with infections or other complications post hematopoietic stem cell transplantation (hsct)

evaluation of diagnostic performance of pro-adm as compared to palliative care therapy (pct) in paediatric and young adult patients with any type of complications after hematopoietic stem cell transplantation or with transplant related complications.

Eligibility criteria:
inclusion criteria: * written informed consent of the parents/legal guardians and patient's assent/consent according to national regulations. for subjects who turn 18 years of age during participation in this study, participation in the future use portion of the study after their 18th birthday requires that they sign the informed consent statement following turning 18 years of age. * age at time of registration from 28 days to less than 39 years of age. * malignant disease (i.e. acute lymphocytic leukemia (all), acute myeloid leukemia (aml), myelodysplastic syndromes (mds)) or nonmalignant disease (e.g. immunodeficiency or inherited disorders of metabolism or hemoglobinopathies etc.) indicated for allogeneic hsct. exclusion criteria: * age less than 28 days * obese patients with body mass index: \> 30 kg/m\^2. * impaired cardiac function: severe cardiac insufficiency indicated by left ventricle ejection fraction (lvef) ≤ 35%. * impaired liver function indicated by bilirubin \>3 times the upper limit of normal (uln), or aspartate aminotransferase/alanine aminotransferase (ast/alt) \>10 times uln * impaired renal function indicated by estimated glomerular filtration rate (gfr), according to the schwartz formula for ages 1-17 and according to cdkepi creatinine equation for ages above 17 years old) \< 60 ml/min/1,73m\^2. * concurrent severe active infection at the start of conditioning regimen
non-invasive substrate evaluation in atrial fibrillation

Conditions: C14.280.067.198

Summary: the study aims to assess the right and left atrial electrophysiological substrate in atrial fibrillation patients using the invasive electroanatomic map (basal and with extraestimulus) as well as its correlation with cardiac magnetic resonance and electrocardiographic imaging. the results will also be compared when the patient is in sinus rhythm and atrial fibrillation.


Eligibility criteria:
inclusion criteria: * atrial fibrillation paroxysmal or persistent with criteria for percutaneous ablation exclusion criteria: * cardiomiopathy (fevi\<40%) or significant valvulopathy. * mri not possible or contraindicated. * previous atrial fibrillation ablation.

Keywords: atrial fibrillation paroxysmal atrial fibrillation persistent atrial fibrillation
an observational study evaluating the safety of topiramate for the prevention of migraine

Conditions: Migraine Disorders

Summary: a 6-month, observational, post authorization safety study for the collection and evaluation of additional safety data on topiramate as a prophylactic treatment for migraines in adult patients. according to current european and international guidelines the safety and efficacy of drugs will be continuously monitored even after their approval and market circulation.the applicable methods of monitoring include: observational studies, voluntarily reported adverse events, clinical trials of iv phase and post authorization safety studies ( pass). post authorization safety studies (pass) during the use of a product are a significant source of information regarding the action of the drug or a therapeutic method under the circumstances of every day clinical practice.

previous studies have shown that topiramate is effective in preventing migraine headaches. this is a 6-month observational study to evaluate additional safety data of topiramate in the prevention of migraine in adult patients. the study duration is 6-months, with 5 study visits during the study. administration of topiramate should be according to current summary of product characteristics (smpc) and daily clinical practice. the decision to prescribe topiramate is decided by the health care professional and it is independent of the protocol. based on the investigator's judgement, patients who enter the study should fulfill the criteria for administration of prophylactic treatment. in this study a total number of 80 patients with diagnosed migraine according to the criteria of the international headache society his (cephalalgia 1998; 8 (suppl7) :1-98) will participate. patients who will be enrolled should be either male or female over 18 years of age, fulfilling the above mentioned criteria and who will agree to sign the written informed consent for the anonymous and confidential use of their medical data with their participation in the study. methods of evaluation include tolerability, laboratory tests, vital signs and body weight and body mass index (bmi). efficacy by assessing migraine attacks, symptomatic medications and headache impact test (hit-6). observational study - no investigational drug administered.

Eligibility criteria:
inclusion criteria: * patients who meet the ihs (international headache society) diagnostic criteria for migraine * patients who satisfy the migraine prophylactic medication criteria exclusion criteria: * ineligible patient according to the marketed summary of product characteristics of topiramate * patient with hypersensitivity to topiramate or to some of its components

Keywords: topiramate migraine headache chronic headache chronic migraine